The European Commission has granted a marketing authorisation for necitumumab (Portrazza), for use in combination with gemcitabine and cisplatin chemotherapy for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy for this condition.
Necitumumab is the first biologic licensed in the EU as a first-line treatment option for this indication.
“Today’s news means that EU patients have a new first-line treatment option for this difficult-to- treat form of lung cancer.
Lung cancer is the leading cause of cancer death in the EU and there is a need for first-line treatment options, especially for squamous non-small cell lung cancer, which currently has a five-year survival rate of less than five percent for patients with metastatic disease”, said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology.1
“Little progress has been made in the treatment of squamous non-small cell lung cancer in the first- line setting in the past two decades”, said Nick Thatcher, Professor of Medical Oncology at Christie Hospital Manchester.
“Nearly a third of lung cancer patients have this specific, difficult-to-treat type of cancer and a new treatment option will be welcomed by the doctors who are caring for them.”
This authorisation is based on the results of the “SQUIRE” trial, an open-label, randomised, multi-centre Phase III trial that compared first-line treatment with necitumumab in combination with gemcitabine and cisplatin to treatment with gemcitabine and cisplatin alone in patients with advanced squamous NSCLC.
This is the first authorisation for necitumumab in Europe and follows US Food and Drug Administration (FDA) approval in November 2015.
1. Cetin, K., Ettinger, D., & O'Malley, C. (2011). Survival by histologic subtype in stage IV nonsmall cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clinical Epidemiology, CLEP, 3.
Source: Eli Lilly
(27 May 2016)
(27 May 2016)